Category Archives: CE marking

We Offer CE Marking Training For Your Organization

Posted on October 5, 2025 by Peter Jolles

F2 Labs offers onsite, and occasionally remote, CE marking Training for your company. Recently, I conducted our CE marking Training for a client of ours in the U.S. As I always do, I found the youngest people in the room … Continue reading →

Posted in Batteries, CE marking, Consulting, EMC Directive 2014/30/EU, EMC Testing, General Product Safety Regulation (EU) 2023/988, GPSR, GPSR (EU)2023/988, International Testing, Lasers, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Pressure Equipment Directive 2014/68/EU, Product Testing, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU, UKCA | Comments Off on We Offer CE Marking Training For Your Organization

So You Need to Field Evaluate Your Equipment – What You Need to Know

Posted on September 25, 2025 by Keith Cooper

If an Authority Having Jurisdiction (AHJ) or electrical inspector has ever informed you that you have failed your inspection or that you require a “UL or CSA Certification” or that your equipment must be “UL/CSA Certified” or “UL/CSA Labeled” we … Continue reading →

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Corrosion | Salt Fog Testing: Like taking your product to the beach

Posted on August 26, 2025 by Keith Cooper

Imagine this: your brand-new, bright, glistening product steps into a chamber. The door closes. Inside, it’s not the day at the spa it expected – instead – it’s a nightmare at the beach. That is Corrosion/Salt Fog Testing.. This testing … Continue reading →

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Essential Performance: What It Is, Why It Matters, and When You Can Say “No Thanks”

Posted on August 22, 2025 by Keith Cooper

Let’s talk about Essential Performance—the term that sounds like it belongs in a motivational poster but is actually a cornerstone of medical device compliance. If you’ve ever stared at a test plan wondering, “Do I really need to define this?”—this … Continue reading →

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Adapting to Evolving U.S.-China Regulatory Dynamics

Posted on August 4, 2025 by Keith Cooper

Medical device companies operating across U.S. and Chinese markets are facing a rapidly shifting regulatory environment. As geopolitical tensions between the two nations intensify, firms must reevaluate their global strategies—particularly when it comes to supply chains, partnerships, and compliance efforts. … Continue reading →

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REACH/RoHS and Continuing Compliance

Posted on July 18, 2025 by Keith Cooper

* Until August 15th, if you mention this blog post we will offer special pricing (20% off) your full REACH and RoHS evaluation with F2 Labs. * We evaluate your device and keep it on autopilot, painlessly. The RoHS Directive 2011/65/EU+(EU)2015/863 started … Continue reading →

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FDA Enforcement Flags Data Integrity Risks at Overseas Labs

Posted on June 6, 2025 by Keith Cooper

The U.S. Food and Drug Administration (FDA) has issued formal warning letters to two overseas third-party labs for serious violations involving data falsification, poor quality controls, and noncompliance with regulatory standards—raising red flags for medical device manufacturers that outsource premarket … Continue reading →

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Cybersecurity and the new Radio Equipment Directive

Posted on May 28, 2025 by Keith Cooper

So, manufacturers, get your cybersecurity capes on. The EU is coming for your gadgets—and it means business. Brace Yourselves: The EU Is Mandating Cyber Hygiene for Wireless Devices Starting August 1, 2025, the EU is tightening the screws on anything … Continue reading →

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Hexavalent Chromium Faces EU Ban Under New Regulatory Shift

Posted on May 21, 2025 by Clare Wolffe

ECHA has proposed a new EU-wide restriction to protect the public from the effects of hexavalent chromium, Cr(Vi). ECHA assessed the risks and found that Cr(Vi) is the most potent workplace carcinogen. People living near industrial sites are also at … Continue reading →

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Unregulated Certificates Warning and The Implications Under EU Law

Posted on April 23, 2025 by Clare Wolffe

Recently, the European Commission updated some of the guidance regarding the EMC, ATEX, and Low Voltage Directives (and others) to include a warning about unregulated certificates. The warning explains that voluntary certificates issued by certification bodies not designated as notified … Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU | Tagged , , , , , , | Comments Off on Unregulated Certificates Warning and The Implications Under EU Law